Abstract
This paper compares the regulation of genetically modified foods in the United States with regulation in the European Union and other countries. The public policy of food safety in the U.S. is then analyzed to determine whether modifications more in line with other countries would be beneficial.

Background
Genetically modified (GM) food, also known as genetically modified organisms (GMO’s) or genetically engineered (GE) food, is when food sources are altered by ways of science and technology. “Genetic modification involves the alteration of an organism’s genetic material by manipulation of its DNA. A set of genes is removed from the DNA of one organism and inserted into the DNA of another, resulting in the production of genetically modified seeds.” The first GM food item that was approved for human consumption was the Flavr Savr tomato, modified so that it would ripen slowly. This technology was first used to produce commercial food sources in 1996 and at this time GM soybeans, corn, and cotton became widely available. By 2005, herbicide tolerant GM soybean seeds accounted for 87% of total U.S. soybean acreage and GM cotton accounted for 60%. In 2007, 281,000,000 million acres of GM crops were cultivated in 23 countries, according to the International Service for the Acquisition of Agri-biotech Applications (ISAAA).

Legal Issues
U.S. Regulations/Policy
Current U.S. law allows for corporations to hold exclusive rights on GM food patents for 20 years, which limits competition. This produces an opportunity for corporations to have a monopoly on food supply. Currently there are three U.S. food regulatory agencies that regulate the development and concerns surrounding GM food - FDA (Food and Drug Administration), USDA (U.S. Department of Agriculture), and EPA (Environmental Protection Agency). These agencies are responsible for doing risk assessments and guidelines for GM products. The FDA, in 1992, determined that “new foods derived from biotech plants are presumed to be GRAS (generally recognized as safe) under the Federal Food, Drug and Cosmetics Act (FFDCA). Therefore, genetically modified foods are no longer under careful monitoring and have not been since first distributed into the food market in 1996. This is problematic because even scientists within the FDA itself disputed whether plants modified through biotechnology modification were identical to non-modified varieties for purposes of food safety. The theory being used to justify GM foods to be considered GRAS is that genetically modified foods are “like” non-genetically modified foods. Many have suggested that reforms need to be made and that the U.S. should develop one specific agency to regulate GM foods, which would reduce confusion about GM foods.

A primary issue is whether GM foods should be labeled as such. No GM label notice is required, though nutrition, ingredients and allergens are required on packaged food labels. Many argue that consumers have a “right to know” whether their food has been genetically modified but the FDA argues that this is not a sufficient justification for mandatory labeling. Currently the FDA does allow producers to label their food as “GMO-free” and the “USDA-Organic” label indicates food that has not been genetically modified. A food product is evaluated for its safety, not whether it was derived from a genetically modified process.

In 2008, Representative Dennis Kucinich introduced to the House the “Genetically Engineered Food Right to Know Act” which would amend the FDCA, requiring GM food to be labeled as such. It has not passed. The FDA’s policy is that “safety concerns should be characteristics of the food product, rather than the fact that new methods are used.”

Three types of labeling regimes can be implemented: positive labels, negative labels, or both. Positive labeling would require all products containing a GM content over a certain percentage to be so labeled. Negative labeling proposes that products containing no genetically modified foods be labeled as such. A policy choice is whether to require labels only on GM foods or also on foods produced from GM components (i.e. livestock feed). If GM foods are to be labeled, what percentage should be the threshold for labeling. GM content can be measured by the percentage of genes that are GM or by the percentage of proteins the plant expresses that are coded for by genes that are foreign from the plant?

Foreseeability
"It is the job of law, drawing from customs, morals, and practical politics, to prescribe who bears the economic risk of harmful consequences from bending nature – those who exploit it or those who are harmed thereby.” Foreseeability helps define and delimit responsibility for causing harm. “If roughly stated, it is largely true that ‘a defendant is responsible for and for such harm as he could reasonably have foreseen and prevented.” With the rate technology is going and how much this impacts our food supply it is vital to take a closer look at liability if GM foods cause harm. The long term effects of GM foods are still largely unknown today and it is quite possible that there may be negative consequences.

“In such a world, where bending nature in elemental ways may unleash any number of risks, we must ask whether the traditional fault-foreseeability model of responsibility for harm is adequate to the task, or whether instead this traditional liability model fails. In such a world, where humans bend nature so far and fundamentally that they may be said to be ‘playing God,’ such conduct undoubtedly will sometimes accidentally produce harmful consequences impossible to predict. Such consequences might be labeled ‘foreseeably unforeseeable’ – the inevitable yet unknowable consequences of monkeying with nature in fundamental ways”

If consumers become ill due to GM foods, is there liability? Under current foreseeability law, probably no one would be liable for such occurrences. Current foreseeability law does not hold producers liable for damages that were unknown or reasonably unforeseeable at the time of production. But what else but unexpected consequences are probable from bending nature in fundamental ways? It is important for regulations to be modified so that producers of GM foods are accountable for harmful consequences.

Patents
Patents provide compensation for novel ideas and inventions. The U.S. grants patents for “any new and useful process, machine, manufacture, or composition of matter, of any new and useful improvement thereof.” A plant patent requires a distinct characteristic that is different from any other plants. Considering that you can receive a patent for a plant due to it having a different characteristic from all other plants, wouldn’t that contradict the idea that genetically modified foods are “like” all other plants?

The Monsanto Company is one of the largest GM plant patentholders. Its Roundup Ready seeds are resistant to common herbicides and pesticides. There is no protection for non-GM farmers who use traditional seeds. There are numerous cases where Monsanto has sued for patent infringement against farmers who unknowingly had GM crops growing in their fields. Contamination of farmers’ land occurs from wind drift and cross pollination due to bee migration patterns. Farmers have been held liable for these patent infringements, resulting in substantial judgments.

Not only can non-GM farmers be sued for patent infringement, but they may also incur their own damages. If a farmer ships food labeled as “organic” and testing finds that it contains GM material, the shipment may be refused and the farmer’s reputation besmirched. A $500,000 shipment of organic corn tortilla chips to Europe was found to contain GE corn in the chips and was refused and returned. If his farm land is contaminated, he has to discontinue his seed saving tradition and begin buying patented seeds so as to not run the risk of encountering a patent infringement lawsuit. Something is seriously wrong with this and requires reform.

Cases Supporting the Legal Issues
United States Regulation Cases
In the Geerston Seed Farms v. Johanns case, the court held that USDA could not deregulate GM alfalfa without consideration of biodiversity impacts, even though the USDA had determined that GM alfalfa was not toxic to humans or animals. Geerston Roundup Ready alfalfa was initially subject to regulation under the Plant Protection Act (PPA). The Animal and Plant Health Inspection Service (APHIS) has jurisdiction over genetically modified organisms. Monsanto requested that the alfalfa not be regulated because it was not a plant pest risk. APHIS granted it and halted regulation of genetically engineered alfalfa strain. The government argued that under the Final Statement of Scope principles GM alfalfa was “like” non-GM alfalfa and thus should be treated as such for purposes of regulation. The court found that the potential elimination of farmer’s choice to grow non-genetically modified crops or a consumer’s choice to eat non-genetically modified food, and an action that potentially eliminates or reduces the availability of a particular plant, has a significant impact on the human environment”

In the Center for Food Safety v. Vilsack (2009) case, non-biotech farmers and consumer groups challenged United States Department of Agriculture’s (USDA) decision to end all regulatory oversight of glysophate-tolerant (Roundup Ready) sugar beets. The USDA made the decision without preparing an Environmental Impact Statement (EIS). The EIS is a complete risk assessment. The court found that USDA violated the National Environmental Policy Act (NEPA) which requires an EIS be made for all “major Federal actions significantly affecting the quality of the human environment.” Monsanto petitioned USDA’s APHIS to deregulate the Round Up ready sugar beets and APHIS agreed to do so after preparing an Environmental Assessment (EA). The EA concluded that the sugar beets wouldn’t cause a significant environmental impact so APHIS never filed an EIS. But the court decided that since the sugar beet seed is almost entirely cultivated in a single valley in Oregon, wind pollination could contaminate local farmer’s crops. APHIS was required to prepare a thorough EIS.

These two cases set the precedent for USDA requirements of conducting a risk assessment of GM foods. This is important to note because the quality of the risk assessments are brought into question by the European Union, discussed later.
The Alliance for Bio Integrity v. Shalala case was brought to court by a combination of groups and individuals, including scientists concerned about the safety and marketing of GM foods. It was against FDA and their policies pertaining to food, primarily challenging the New Plant Policy as a violation of the National Environmental Protection Act (NEPA) because the FDA presumed that GM foods are “generally recognized as safe” (GRAS) and this in turn was the reasoning behind the FDA’s refusal to label genetically engineered foods as GE/GM. The court found that the plaintiffs did not provide efficient evidence that GM foods are not GRAS. The plaintiffs then contended that GE foods are materially different than their natural counterparts, which was the opposite of what the FDA was claiming. The courts held that GE foods, as a class, are not established as being inherently dangerous or that they differ in some material way and thus FDA is not required to label them differently. Due to this case, labeling regulations for GM foods have not been implemented in the United States.

Patents and Cross Contamination Cases
The Diamond v. Chakrabarty case was a landmark Supreme Court case that occurred in 1980 and was the precedent allowing patents to be developed for living organisms for human consumption. The outcome was decided because the United States code provides that “a live human-made micro-organism is patentable.” It is because of this case that companies have the ability to monopolize the food industry through patents.

In Monsanto v. Scruggs, Monsanto sued a farmer for illegally using patented seeds and not paying for them. Scruggs argued that he had purchased the seeds but never signed a license agreement, and under the doctrine of patent exhaustion, he had the right to use the seeds free from patent restriction. The courts ruled in favor of Monsanto stating that patent exhaustion was inapplicable, “the fact that a patented technology can replicate itself does not give a purchaser the right to use replicated copies of technology, and furthermore, applying the first sale doctrine to subsequent generations of self-replicating technology would eviscerate the rights of the patent holder.” The court ruled against Scruggs because Monsanto owned the patents.
In Monsanto v. Schmeiser, Monsanto sued Percy Schmeiser for having plants in his field that contained glyphosate-resistant canola plants and he did not have a license to use the Monsanto seeds. Schmeiser argued that he did not knowingly acquire or plant the patented seeds/crops and that windborne cross contamination had occurred. The trial judge ruled in favor of Monsanto claiming that “Schmeiser knew or ought to have known that those plants were glyphosate-resistant when he saved their seeds in 1997 and planted them the following year.” This case raises issues having to do with farming techniques of saving seeds and cross contamination. The precedent now holds farmers to be liable for circumstances that may be out of their control. This case has not been referenced by other cases yet.

The Monsanto v. Dawson case was another case where Monsanto sued a farmer for having patented crops on the land. The case confirms that the inadvertent presence of contaminated crops does not protect the innocent possessor from infringement and farmers will be liable. The court ruled that “if farmers grow non-transgenic crops in an area where transgenic crops are grown, there could be a presumption that they ‘ought to know’ of the possible presence of protected transgenic seeds on their fields.”

Foreign Law
The European Union (EU) has stricter laws than the U.S. regarding genetically modified foods. The EU has contractual obligations under the World Trade Organization (WTO) not to negatively discriminate or impose trade restrictions on imports, except under certain conditions. The EU tried to ban the growth and importation of GMOs entirely, but the U.S., Canada, and Argentina successfully challenged this ban and the WTO found that the ban did indeed violate the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) because the ban was not based on risk assessments satisfying the definition of the SPS Agreement and therefore done without sufficient scientific evidence. This attitude against GM foods has spread to other countries, including Australia, New Zealand, Japan, Indonesia, and Africa. Some African governments are rejecting shipments of GM food aid, resulting in unnecessary starvation. The EU requires any food product containing more than 0.9% of genetically modified content be labeled as “genetically modified.”

The labeling requirements are much stricter for two reasons: distrust of regulators has led consumers to demand harsher regulations and European regulators approach risk regulation conservatively – they evaluate both the product and production process (whereas the U.S. evaluates based on the product, not process) and they use the precautionary principle. Regulations on labeling food packages follow a three category form in Europe. Pre-cooked or packaged food with a list of ingredients - the GM ingredient must be labeled as genetically modified within the list of ingredients. Packaged food without a list of ingredients - the text stating genetically modified must be clearly visible on the label. And for small packages or unpackaged food - there must be a displayed sign somewhere close to the product labeling it as genetically modified.

Other countries also have labeling policies in effect. Canada and Argentina allow voluntarily labeling. Australia and New Zealand require products containing more than 1% of genetically modified material be labeled. South Korea and Indonesia require labeling for 3% or more. And Japan requires labeling for at least 5% GM content.

Australia developed The Gene Technology Act of 2000 that came into force June 21, 2000 and became the first national scheme for regulation of GM food in Australia. The object of the Act is to protect the health and safety of the people and the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks by regulating certain dealings with GMOs. According to the act, anyone planting a GM crop must have the authority of a license which can be provided by the Gene Technology Regulator. The regulator is responsible for doing a risk assessment and to monitor field work and selling of the product. The GM farmers are responsible for not only potential harm to human health and safety and to the environment, but also for any economic loss resulting from contamination of non-GM seeds by GM seeds. Non-GMO farmers are also protected from patent infringement liability. This all differs significantly from the current U.S. regulation.

Benefits of Genetically Modified Foods
GM seeds enhance agricultural productivity. Farms produce a larger quantity of crops in a shorter period of time. Farmers increase profits significantly.
GM crops are also developed to be resistant to pesticides and herbicides, thereby decreasing the number of treatments required. Less spray results in less contamination of the environment. Less pesticide and herbicide allows farmers to use “no-till agriculture,” which leaves soil and weed cover undisturbed over winter, greatly reducing soil erosion and loss of groundwater.

GM seeds open new areas for farming, in soils that would not be sustainable otherwise. This can be very beneficial for developing countries.
One health benefit that GM food provides is that GM plants can be altered for more vitamins and nutritional value. GM foods may have a longer shelf life, staying riper and healthier longer than non-GM foods. One of the most significant benefits that GM foods may provide is the ability to feed a rapidly growing population, predicted to reach more than nine billion by 2050. The United Nations estimates that agricultural output will have to rise 50% by 2030 to meet this demand. Dr. Jacques Diouf, Director-General of the United Nations Food and Agricultural Organization (FAO), has said ‘GMO’s can help increase the supply, diversity and quality of food products and reduce costs of production and environmental degradation, as the world still grapples with the scourge of hunger and malnutrition…’

Risks from Genetically Modified Foods
While benefits of GM foods are significant, there are also risks. These are health concerns, negative environmental impacts, socio-economical issues, ethical concerns, and legal matters.

Health risks are the most significant, considering that GM foods have not been around long enough to have had extensive scientific studies done to determine potential health hazards. GM foods may carry an antibiotic-resistant gene, which one commentator has warned, “some of the antibiotics used for this purpose are still used to treat human illnesses, and there is concern that resistance to the antibiotics could be transferred to humans and animals through food and feed products.”

Environmental concerns include introducing new genes into existing crops that could affect the surrounding environment. Genes of the GM crop could transfer to wild or domesticated varieties of the species. The fear is that a new “super-weed” might result that is resistant to current farming methods and potentially produce an indestructible plant. Other fears are loss of genetic diversity within crop species or even the destabilization of entire eco-systems. If certain crops are wiped out, or their genetic DNA changes, it could mean a loss of food source for birds and insects, which would throw the ecosystem out of balance.

The growing power of multinational corporations over traditional farming is a concern. Big corporations control the food industry through intellectual property laws. Traditional farmers could be pushed out of business by corporate farmers.

Combining technology advancements and nature brings ethical dilemmas. The major concern is that widespread acceptance of GM crops will cause unintended consequences. It is said that it can be seen as an “immoral application of agricultural biotechnology because the process of modifying genes creates living things that would never occur in nature.” Scientists are twisting nature’s fundamental properties, which raises questions on the fairness and logic of allowing enterprises to escape responsibility for harmful consequences behind an impenetrable shield of unforeseeability. GM foods are the potential Frankenstein of our times.

Conclusion
This paper has analyzed benefits and risks of GM foods in relation to current policy and regulations. The major benefit of GM foods is the supply of food to a growing population. While population growth rate is daunting and food supply is a legitimate concern, food safety should not be ignored. Balancing of interests shows that, at a minimum, label notices should advise U.S. consumers of GM food content. Further research is required as to unexpected consequences of GM food and feed components, with sufficient regulation to protect the public.

E.U. regulations provide a reasonable model that should be adopted into U.S. law. The stricter Australian regulations should also be considered as guidelines for future U.S. laws.